Events

Device Recall Verify BowieDick Test Card 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Steris Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    63129
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2417-2012
  • 사례 시작날짜
    2012-07-03
  • 사례 출판 날짜
    2012-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112673
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Sterilizer, chemical - Product Code MLR
  • 원인
    Steris has learned that the verify bowie dick test cards are not performing to product specifications. specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.
  • 조치
    Steris Corporation sent a Urgent Voluntary Recall Notice dated July 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and compare the lot numbers printed on the box with the listed lots. If they have products from the affected lot numbers to contact STERIS Customer Service for account credit. After notifying STERIS of the amount of recalled product on hand they are to immediately destroy the product. Distributors are to also notify their customers of the recall. They are to send a copy of the Customer Recall Notice. They are to inventory their stock and notify STERIS of any remaining recalled product for replacement product. All recalled product should be destroyed. Please contact your STERIS Account Manager or STERIS Customer Service at 1-800-548-4873.

Device

Device Recall Verify BowieDick Test Card
  • 모델명 / 제조번호(시리얼번호)
    Model #S3098, Serial #"s: H20013, H20014, and H20016.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, IA, IN, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK,OR, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY. and the country of Canada.
  • 제품 설명
    Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 || The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle, the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle, the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used, usually before the first sterilization cycle.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • 제조사 주소
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • 제조사 모회사 (2017)
    Steris Corporation
  • Source
    USFDA